Cleared Traditional

VARELISA MPO ANCA, MODEL 17648/17696

K041040 · Sweden Diagnostics (Germany) GmbH · Immunology
Jun 2004
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K041040 is an FDA 510(k) clearance for the VARELISA MPO ANCA, MODEL 17648/17696, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on June 16, 2004, 55 days after receiving the submission on April 22, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K041040 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2004
Decision Date June 16, 2004
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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